Disposable knee mold

ABSTRACT

An orthopedic implant device and method is disclosed. Specifically, a knee mold system is disclosed, including elastic tibial and femoral molds, each of which may be configured and dimensioned as a unitary mold for in situ placement during a surgical procedure. Each mold may be manufactured from an elastic material that may be disposable. The tibial mold may further comprise a sidewall forming a cavity, markings for relative depth measurement, and depth rings for use as a guide for scoring, cutting, and/or trimming and tearing away an excess portion of the tibial mold. The femoral mold may further comprise a sidewall defining a cavity, two legs extending from a body of the femoral mold for forming the artificial condyles, and an eyelet for aiding in placement and removal of the femoral mold. The resulting prosthetic tibial and femoral components may form an articulation surface that mimics, at least in part, the natural articulation surface of the knee.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication No. 60/364,061, filed Mar. 13, 2002, which is herebyincorporated by reference herein in its entirety, including but notlimited to those portions that specifically appear hereinafter, theincorporation by reference being made with the following exception: Inthe event that any portion of the above-referenced provisionalapplication is inconsistent with this application, this applicationsupercedes said portion of said above-referenced provisionalapplication.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable.

BACKGROUND OF THE INVENTION

[0003] 1. The Field of the Invention

[0004] The present invention relates generally to implants for use inorthopedic surgery, and more particularly, but not necessarily entirely,to molds for forming temporary orthopedic implants in the knee.

[0005] 2. Description of Related Art

[0006] The anatomy of the knee is primarily composed of two major bones,the tibia and the femur. These two bones meet to form a hinge jointbetween the proximal tibia and the distal femur. The knee joint isprotected by the patella, or the kneecap. The knee joint is cushioned byarticular cartilage that covers the ends of the tibia and femur, as wellas the underside of the patella. The lateral meniscus and medialmeniscus are pads of cartilage that further cushion the joint, acting asshock absorbers between the bones.

[0007] A healthy knee joint is able to withstand great forces that areexerted as the knee flexes and extends and supports the weight of thebody. However, when the knee joint becomes diseased, damaged or isotherwise unable to withstand the forces required of that joint, it maybecome necessary to reconstruct or replace the knee joint. Whenreplacement is necessary, the natural knee joint is replaced with aprosthetic knee joint. A typical prosthesis includes a femoral componentand a tibial component. During a replacement knee surgery, typicallyportions of both the tibia and femur must be resected to allow theplacement of prosthetic tibial and femoral components, which areanchored to the respective bones.

[0008] Sometimes, a small percentage of patients who undergo a totalknee replacement surgery suffer from infections in the knee joint at thesurgical site. To alleviate the effects of the infection, a two-stagerevision of the failed knee replacement is necessary. The two-stagerevision includes the following procedures. First, the prosthesis mustbe surgically removed and the site debrided and cleansed extensively inorder to rid the site of the infection. Before a new, permanentprosthesis can be placed in the old surgical site, the site must be freeof infection. It is typical for a temporary antibiotic-impregnatedcement spacer to be used as part of the therapy to rid the site ofinfection. Disinfecting the site of infection may take between 6-8 weeksand 3-4 months in most circumstances. Therefore, it is common forsurgeons to replace the old prosthetic knee with a temporary implant,typically made of bone cement, during the 6-8 week period while theinfection is cleared up and before the new prosthesis is surgicallyimplanted. The second and final step requires a separate revisionsurgery to then replace the temporary implant with a permanentprosthetic implant.

[0009] In the past, surgeons have been left to their own devices whenforming cement implants, including the use of negative molds. Theprocess of making a negative mold consists of the surgeon creating amold by inserting a portion of bone cement into a bowl or other mixingcontainer and allowing the cement to nearly cure. Prior to completecuring of the bone cement, the surgeon inserts the articulating end ofthe femoral component into the bone cement to create a mold. Using thatmold, the surgeon then applies an oil to the mold creating a barrier forseparating the cement implant from the cement mold. After applying theoil, cement may be poured into the mold allowing it cure, after whichthe surgeon attaches the resulting bone cement implant onto the femur asa temporary replacement. Negative molds may be used for both femoral andtibial components alike.

[0010] Other methods used in the past of forming temporary implantsinclude surgeons creating the implant with their own hands or simplyputting a block of cement between the tibia and the femur to act as aspacer. However, there are many problems associated with such methodsand designs, namely increased surgical time due to the preparation andformation time needed for creating the implant. Particular problemsassociated with the block or spacer method include completelyimmobilizing the knee in an extended position, after surgery, for theentire 6-8 week period, which in turn leads to soft tissue damage andfurther complicates the revision surgery. Therefore, reproducing theknee joint using temporary implants that simulate the natural tibial andfemoral components of the knee joint is much more desirable because itpermits the patient to move his/her leg through a minimal range ofmotion. The range of motion, while limited, significantly increases thepatient's comfort over the 6-8 week period allowing the patient to bendhis/her knee for sitting in a chair or for riding in a car and alsoincreases the ease of the revision surgery because the soft tissue hasnot been damaged to the same extent as when the knee is completelyimmobilized.

[0011] Attempts have been made in the prior art to provide alternativesto surgeons creating their own negative molds or even molding atemporary implant by hand. For example, U.S. Pat. No. 6,155,812 (grantedDec. 5, 2000 to Smith et al.) discloses a cement mold for use in forminga temporary orthopedic implant used in an orthopedic surgical procedure,said mold including a first and second mold joined together by acoupling mechanism. This device is characterized by severaldisadvantages, including the need for many different sized molds toaccommodate the differences in size of patients tibias and femurs, theneed for multiple pieces that must be joined together and the need touse the mold outside the patient's knee joint such that the implant mustfirst be formed and then attached to the tibia or femur in two separatesteps.

[0012] There are several other temporary bone cement molds known in theprior art, such as that disclosed in an article entitled “TemporaryArticulating Methylmethacrylate Antibiotic Spacer (TAMMAS)—A New Methodof Intraoperative Manufacturing of a Custom Articulating Spacer” foundin The Journal of Bone and Joint Surgery 83:S92-97 (2001). Thisreference discloses a method of conforming sterilized, heavy aluminumfoil to the distal portion of the femur or the proximal portion of thetibia such that an aluminum mold is created. Bone cement is later pouredinto the mold and the cement is formed into the shape of the femoral ortibial component. However, this technique is disadvantageous because itrequires the surgeon to conform the foil to the bone and to further formthe bone cement into the shape of a femoral or tibial component. In thissetting, another disadvantage in the aluminum foil is its ductility. Thefoil is unable to spring back into its original shape or position makingit very difficult to work with and to maintain its shape as the cementis poured into the mold and while the cement is allowed to cure.

[0013] Other attempts have been made to provide a mold that is capableof maintaining its original shape. However, such attempts have proven tobe unsuccessful because the rigid, non-resilient nature of the materialsused, such as metal or a metal alloy. The rigid, non-resilient nature ofa metal mold allows the mold to be used repeatedly. However, there areseveral disadvantages associated with non-resilient molds, for example,non-resilient molds do not have the requisite flexibility to be used insitu, as it is difficult to remove the implant from the mold and thereis no flexibility for the mold to be conformed to various anatomicaldifferences in the bones.

[0014] It is noteworthy that none of the prior art, known to applicants,provides an elastic mold capable of being attached in situ that furtherprovides for a one piece mold capable of attaching to various sized bonecomponents. There is a long felt need, illustrated by the statistics ofincreased surgical success of the revision surgery when a patient has alimited range of motion in the knee joint, for an elastic mold for insitu surgical use that allows the bone cement replacement implant toconform to the shape of the knee bones.

[0015] The prior art is thus characterized by several disadvantages thatare addressed by the present invention. The present invention minimizes,and in some aspects eliminates, the above-mentioned failures, and otherproblems, by utilizing the methods and structural features describedherein.

[0016] The features and advantages of the invention will be set forth inthe description which follows, and in part will be apparent from thedescription, or may be learned by the practice of the invention withoutundue experimentation. The features and advantages of the invention maybe realized and obtained by means of the instruments and combinationsparticularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above and other features and advantages of the invention willbecome apparent from a consideration of the subsequent detaileddescription presented in connection with the accompanying drawings inwhich:

[0018]FIG. 1 is a perspective view of a tibial mold and resulting tibialimplant made in accordance with the principles of the present invention;

[0019]FIG. 2 is a perspective view of the tibial mold of FIG. 1, withthe top of the mold turned upside down illustrating an interior cavity;

[0020]FIG. 3 is a perspective view of the tibial mold of FIG. 1, withthe mold illustrated in an upright position;

[0021]FIG. 4 is a perspective, rear view of a femoral mold made inaccordance with the principles of the present invention;

[0022]FIG. 5 is a perspective, front view of the femoral mold of FIG. 4illustrating an interior cavity;

[0023]FIG. 6 is a perspective view of a femoral mold and the resultingfemoral implant made in accordance with the principles of the presentinvention; and

[0024]FIG. 7 is a perspective view of the femoral mold with theresulting femoral implant and the tibial mold with the resulting tibialimplant together comprising a mold system made in accordance with theprinciples of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0025] For the purposes of promoting an understanding of the principlesin accordance with the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended. Anyalterations and further modifications of the inventive featuresillustrated herein, and any additional applications of the principles ofthe invention as illustrated herein, which would normally occur to oneskilled in the relevant art and having possession of this disclosure,are to be considered within the scope of the invention claimed.

[0026] Before the present device and methods for surgically positioningthe disposable knee mold, in situ, are disclosed and described, it is tobe understood that this invention is not limited to the particularconfigurations, process steps, and materials disclosed herein as suchconfigurations, process steps, and materials may vary somewhat. It isalso to be understood that the terminology employed herein is used forthe purpose of describing particular embodiments only and is notintended to be limiting since the scope of the present invention will belimited only by the appended claims and equivalents thereof.

[0027] It will be appreciated that while the present invention will bedescribed in connection with a knee and as a mold system for a knee, theprinciples of the present invention may be applied equally to otherareas of the body and in other joints, for example, the hip joint or theshoulder joint.

[0028] Applicants have discovered that the surgical attachment of kneeimplants is greatly enhanced by using an elastic mold, in situ, to castthe tibial and femoral components of the knee implant, complete witharticulating surfaces that simulate the biomechanics of the naturalbone, by utilizing bone cement or other compounds known in the art forcreating articulating surfaces, thus simulating the articulatingsurfaces of the natural knee joint. Applicants have thus conceived of anelastic mold system capable of in situ attachment of an implant onto thebones of the knee joint that may be utilized on several different sizesof bones and that may be easily removed or separated from the resultingimplant and bone after the implant has been formed.

[0029] The elastic tibial mold and elastic femoral mold of the presentinvention together form a temporary prosthetic implant that may be usedas a temporary knee replacement when a patient's knee joint requires atotal knee replacement surgery or a revision knee replacement surgery,when the knee contains an infection. Prior to implanting a permanentknee replacement, the infection in the knee must be eliminated throughdebridement and loading the infected area with antibiotics. Loading theinfected area with an antibiotic directly, and also loading thebiocompatible material used to form the temporary prosthetic implantwith antibiotics, and thereafter implanting said temporary prostheticimplant into the bone, is considered to be an effective process foreliminating the infection. After 3-4 months, the infected area should beready to receive a permanent prosthetic knee implant. Applicants havediscovered a way to accomplish the above process by utilizing the tibialmold and femoral mold of the present invention to form said temporaryprosthetic implant directly on the bone, in situ, during surgery. Theelastic tibial mold and femoral mold aid in the process of distributingantibiotic to the infected area of the bone, while permitting some rangeof motion in the knee joint while the infected area is healing.

[0030] Referring now to the figures, a disposable knee mold system 10(illustrated best in FIG. 7) is illustrated for creating a kneereplacement in accordance with the present invention, which maygenerally comprise two components, a tibial mold 100, illustrated inFIGS. 1-3, and a femoral mold 200, illustrated in FIGS. 4-6. It will beappreciated that both the tibial mold 100 and the femoral mold 200 maybe manufactured from an elastic material, such as silicone or a rubbermaterial, or any other polymeric material that exhibits similar physicalproperties as silicone, namely elasticity and biocompatibility. It willbe appreciated that the material used to manufacture the tibial mold 100and the femoral mold 200 must not adversely react with the biocompatiblematerial used to form the prosthetic implants 50 and 75. It should benoted that the tibial mold 100 and the femoral mold 200 may also be madeof any other material which exhibits similar elastic properties assilicone. It will be appreciated that the tibial mold 100 and thefemoral mold 200 may both be manufactured from said elastic material andmay be designed for one time use and then disposed of, thus creating amold system that may be scored, cut, trimmed or otherwise altered by asurgeon at the time of surgery in order to accommodate the differinganatomies of each patient.

[0031] It will be appreciated that the femoral mold 200 forms a femoralcomponent 75, or a first portion, of the entire prosthetic implant,while the tibial mold 100 forms a tibial component 50, or a secondportion, of the prosthetic implant. It should be noted that any suitableelastic material currently known, or which may become known in thefuture, in the art for manufacturing an elastic mold system and whichaccomplishes the principles and designs of the present invention asdisclosed herein is intended to fall within the scope of the presentinvention.

[0032] Further, the tibial mold 100 and the femoral mold 200 may each bemade of a solid, unitary piece. The femoral mold 200 may be stretchedover bones such that the femoral mold 200 may be adapted to fit overvarious sizes of bone, as will be discussed more fully below. It will beappreciated that both the tibial mold 100 and the femoral mold 200 maybe manufactured using a variety of techniques currently known in theart, or which may become known in the future, for example, injectionmolding, compression molding or any other suitable technique may beused.

[0033] It will further be appreciated that the biocompatible materialused to form either the tibial component 50 or femoral component 75 maybe made from bone cement or other material that is presently known, orwhich may become known in the future, in the art to form such implants.Therefore, it should be noted that a myriad of other materials that arealso biocompatibly suitable for surgical use may be utilized as theimplant material without departing from the scope of the presentinvention.

[0034] Referring to FIGS. 1-3, the tibial mold 100, also referred toherein as a second mold, may comprise a main body portion 105, which mayitself comprise a sidewall 102, an inner surface 110, an outer surface120, an inner base surface 160, an outer base surface 160 a and a cavity130, sometimes referred to herein as a second cavity. The cavity 130 maybe defined by the sidewall 102, sometimes referred to herein as a secondsidewall, that extends around a perimeter 101 of the main body portion105 of the tibial mold 100 and may be part of the inner surface 110. Itwill be appreciated that the structural features and elasticcharacteristics that permit the mold 100 to be located directly on theproximal surface of the tibia, may be referred to herein as a means forattaching the mold, in situ, directly to the patient's bone, and themeans for attaching may comprise a circumferential elastic contactingmeans for circumferentially contacting a proximal portion of the tibia.

[0035] The inner base surface 160 of the tibial mold 100 may comprise atleast one depression 170, and at least one protrusion, illustrated inFIG. 2 as two protrusions 172 and 174 (explained below in more detail)that may form an uneven surface in the inner base surface 160. The atleast one depression 170 and the at least one protrusion 172 and 174 maybe configured for forming a corresponding and opposing set of at leastone protrusion and at least one depression in a tibial component 50 suchthat a natural tibial plateau may be simulated, at least in part. Itwill be appreciated that the uneven surface, if utilized, will only beuneven with respect to the inner base surface 160, and is not requiredto be uneven on the outer base surface 160 a, although the outer basesurface 160 a could be uneven.

[0036] The cavity 130 may be characterized as having an open face 130 afor receiving an amount of biocompatible material, such as bone cement,such that the biocompatible material may be configured for use as thetibial component 50. The tibial mold 100 with its open face 130 a, maybe further characterized by the absence of a substantially enclosedcasing. As used herein, whether for the tibial mold 100 or the femoralmold 200, the phrase “substantially enclosed casing” may be defined as amold that is substantially sealed along a majority of its outer surfacesuch that an inner cavity is substantially surrounded on all sides, andthe mold comprises at least one opening or port configured for ventingthe sealed mold, or for allowing the input of a biocompatible materialtherein, for example bone cement.

[0037] The outer surface 120 may define an outer, external shape of thetibial mold 100, and may be located opposite the inner surface 110. Theouter, external shape of the tibial mold 100 may be shaped substantiallyas a kidney and corresponds to a cross sectional shape of the proximalportion of the natural tibial bone. It should be noted that the outershape of the tibial mold 100 may be configured to correspond to theouter shape of a patient's tibial plateau, and any suitable outer shapefor simulating the patient's tibial plateau may be used by the presentinvention.

[0038] A thickness “T” of the tibial mold 100 may be formed between theinner surface 110 and the outer surface 120. It should be noted that thethickness “T” may be altered to accommodate differing design features orcharacteristics requiring a thicker or thinner wall thickness. It is tobe understood that any wall thickness of the tibial mold 100 of thepresent invention may be utilized and is contemplated by the presentinvention. By modifying the thickness “T” to be of any desiredthickness, one of skill in the art may readily find a desirablethickness “T,” without undue experimentation, to implement the requisiteelasticity needed for a particular purpose for the tibial mold 100, aswell as for the femoral mold 200.

[0039] The cavity 130 of the tibial mold 100 may be configured anddimensioned to receive the biocompatible material therein, for examplebone cement. It will be appreciated that the tibial mold 100 may beplaced, in situ, onto a patient's proximal tibial bone to form theresulting tibial component 50 directly thereon. The inner base surface160 may have at least one depression 170 and at least one protrusion,illustrated in FIG. 2 as two protrusions 172 and 174, spaced in aparticular arrangement such that the depression 170 and the protrusions172 and 174 collectively result in a contour of the tibial component 50.It will be appreciated that the contour of the cavity 130 and theresulting tibial component 50 may simulate, at least in part, thesurface of the natural tibial plateau. The resulting contour of thetibial component's 50 articulating surface is illustrated best inFIG. 1. It will be appreciated that the term “contour” as used hereinmay refer to the surface of the mold 100 that produces the articulatingsurface of the resulting tibial component 50, whether the articulatingsurface is flat, partially contoured with protrusions, or depressions,or a combination of both, or fully contoured with protrusions, ordepressions, or a combination of both.

[0040] The depressions 52 and 54 of the tibial component 50 may beformed as a result of the cement being formed around the protrusions 172and 174 of the tibial mold 100 (illustrated best in FIG. 2),respectively, which protrusions 172 and 174 may be located on the innerbase surface 160. Further, depressions 52 and 54 may be configured anddimensioned to correspond with the prosthetic femoral condyles of thefemoral component 75 in an articulating relationship, such that a newtemporary joint may be formed, thus simulating, at least in part, thenatural articular surface of the joint. It will be appreciated that bysimulating at least a part of the natural articular surface of thejoint, the patient may have at least a limited range of motion in thenewly formed temporary prosthetic joint, during the time period betweenthe removal of the old permanent prosthetic joint and the revisionssurgery to implant a new permanent joint.

[0041] It will be appreciated that the prosthetic tibial plateau createdby the tibial mold 100, and the prosthetic femoral condyles created bythe femoral mold 200, while simulating the biomechanics of the naturaljoint to at least a limited extent, may not create a full range ofmotion in the joint. However, the prosthetic components that result fromusing the tibial mold 100 and the femoral mold 200 may be used to helpthe patient have at least some mobility and some limited range of motionin the joint. By so doing, the joint may not be immobilized completely,but may be able to bend and flex, thus avoiding soft tissue injury andincreasing the patient's comfort during the 6-8 week time period whenthe prosthetic components are being utilized.

[0042] Further, the tibial mold 100 may comprise a depth referencefeature, which depth reference feature may comprise a plurality of depthrings 150 and a plurality of markings 140. The depth rings 150 and theplurality of markings 140 may be formed on the outer surface 120 of themain body portion 105. It will be appreciated that a depth referencefeature could also constitute the basic shape and size characteristicsof the mold 100, which a skilled surgeon may utilize intuitively as adepth reference feature without the aid of depth rings 150, markings140, and the like. It will be appreciated that the markings 140, ifused, may correspond to different depth measurements used for increasingor decreasing the overall thickness of the tibial component 50 and bonecement needed to fit an extension gap between the tibial plateau and thefemoral condyles. The markings 140 may be comprised of a series ofnumerals, or may be comprised of any other symbol used as a referencefor representing a predetermined depth. It will be appreciated that alarge extension gap between the tibia and the femur corresponds to agreater depth measurement needed to form the resulting tibial component50, which is thick enough to properly fit the extension gap. It will beappreciated that the resulting tibial component 50 may ultimatelyprovide an articulating surface in the knee joint.

[0043] In practice, the markings 140 may aid the surgeon in determiningthe proper thickness of the bone cement to be used for properly fittingbetween the extension gap, and for determining the proper spacingbetween the tibia and the femur. The markings 140 may be configured suchthat a surgeon may use the markings 140 of the tibial mold 100 as aguide for visually determining the thickness of bone cement to be usedto fit the gap created between the tibia and femur in the knee joint.The thickness of the resulting tibial component 50 may be changed usinga single tibial mold 100, according to the anatomical requirements ofeach individual patient.

[0044] The surgeon may determine the required thickness of the tibialcomponent 50 using a variety of different methods, including: (1)forming the femoral component 75 first using the femoral mold 200, andthen measuring the remaining gap using: (a) a spacer block, or (b)calipers, and then sizing the tibial mold 100 to correspond with theremaining gap; (2) gauging the size of the entire gap first, using (a)the spacer block, or (b) calipers, wherein the femoral component 75comprises a predetermined thickness designed to occupy a predeterminedspace in the entire gap, and then subtracting the predeterminedthickness of the femoral component 75 to arrive at a gap size for thetibial component; or (3) estimating the size of the gap by placing thetibial mold 100 near the gap to measure the distance between a proximalend of the tibia and a distal end of the femur using the markings 140 asa visual reference. It will be appreciated that the above may bereferred to herein as a means for determining a gap size between theproximal tibia and distal femur. It will be appreciated that the spacerblock or calipers may be used to gauge or measure the gap, indicating tothe surgeon at which marking 140 to score, cut and/or trim the mold.Different spacer block sizes may correspond to each marking 140indicated on the mold 100. After the proper thickness has beendetermined, the surgeon may use a scalpel or other instrument to score,cut, trim off and/or help peel off the excess portion of the tibial mold100, specifically using depth rings 150 as a guide, creating a specificand properly sized mold 100 for that particular patient.

[0045] It will be appreciated that depth rings 150 may comprise a seriesof indentations, or grooves, for example V-grooves, or may even compriseprotrusions in the outer surface 120 of the main body portion 105 forrunning an instrument, such as a scalpel or other surgical device alongan edge, therein such that the series of indentations, or grooves mayact as a guide to score, cut and/or trim the tibial mold 100. The depthrings 150 may correspond to the proper markings 140 and identify theproper thickness needed for the tibial component 50 to properly fitbetween the tibia and the femur. It will be appreciated that the surgeonmay score, cut and/or trim the tibial mold 100 such that there is enoughexcess mold to securely wrap around the patient's proximal tibia whilethe biocompatible material, such as bone cement, cures on the bone.

[0046] After the thickness determination has been made, and the tibialmold 100 has been scored to the desired depth or desired thickness,biocompatible material, such as bone cement, may then be placed into thecavity 130 of the tibial mold 100. Prior to the biocompatible materialcompletely curing, the tibial mold 100 may be located on the tibial bonewhere the biocompatible material may finish the curing process andharden. The tibial mold 100 may be located on a portion of the tibialbone by placing the tibial mold 100 into contact with a proximal surfaceof the tibia and/or surrounding tissue such that the biocompatiblematerial may be positioned on the proximal surface of the tibia tothereby form the tibial component 50 directly on the proximal tibia.

[0047] It will be appreciated that the tibial mold 100 may be held inposition by the surgeon or other surgical team member until thebiocompatible material at least partially cures. It will further beappreciated that other mechanisms may be utilized by those of skill inthe art to hold the tibial mold 100 in contact with the proximal surfaceof the tibia while allowing the biocompatible material to at leastpartially cure. The biocompatible material may cure directly on theproximal surface of the tibia, whether the curing process is partial orcomplete. When the tibial mold 100 is located on the tibial bone, aportion of the biocompatible material may enter into a cavity formed inthe tibial bone, thus securing the resulting tibial component 50 to thetibial bone. Removal of the tibial mold 100 from the resulting tibialcomponent 50 may be accomplished by scoring, cutting, tearing, ripping,splitting, peeling or otherwise manipulating the elastic tibial mold 100from off of the tibial component 50 and tibial bone.

[0048] Referring briefly to both the tibial mold 100 and the femoralmold 200, it will be appreciated that elasticity is a feature of thepresent invention that may permit the femoral mold 200 to beadvantageously stretched and wrapped around a bone during attachment andremoval such that the mold 200 may be used in situ, such that a singlemold may be used on a variety of differently sized bones. Elasticity mayfurther permit the tibial mold 100 to be located, in situ, and may alsopermit the mold 100 to be scored or cut for peeling a portion of themold away, or be trimmed away, thus permitting a single mold 100 to beused and adjusted to fit a number of different extension gap sizes andbone dimensions. The ability for the mold 100 or 200 to be readilypeeled, scored, cut or trimmed due to its relatively low hardness mayalso be advantageous to separate the mold from the implant duringremoval.

[0049] The tibial mold 100, being elastic, can be constructed from asilicone or rubber material that possesses elastic memory, which causesthe mold 100 to return to its original shape or position after beingdistorted. Therefore, the elastic memory of the material may provideenough strength for the mold 100 to substantially maintain its shapeduring the location of the prosthetic component 50 to the bone, and mayalso be flexible enough that one mold 100 may be used on severaldifferent bone sizes, while providing the ability to be peeled, cut, ortorn away from the component 50 without adversely affecting thecomponent 50.

[0050] It will be appreciated that a single mold may be used forattachment to bones of various sizes within a given range. It willfurther be appreciated that more than one size of mold 100 and 200 maybe provided to accommodate all the potential possibilities in anatomicaldifferences of patients. For example, three different mold sizes may beprovided, such that each mold size has a different range of bone sizeson which the mold 100 or 200 will fit, i.e. small, medium, and large. Itwill be appreciated that more or less than three mold sizes may be usedby the present invention, dependent upon the desired range of bones tobe fitted by the molds.

[0051] Referring back to the tibial mold 100, the markings 140 mayfurther delineate depth rings 150. The depth rings 150 may be formedeither partially on or completely around the exterior of the tibial mold100 such that the surgeon can immediately identify the requisite depth.Having identified a sufficient depth, the surgeon may shorten the tibialmold 100 using the depth rings 150 as a guide to score, cut and/or trimalong the depth rings, due to the elastic nature of the mold, with ascalpel and peel away the excess portion of the tibial mold 100. Thus,because of the elastic capabilities of the material used to manufacturethe tibial mold 100, a single mold 100 may be used to form many tibialcomponents 50, of varying sizes in order to accommodate the differinganatomies of each patient, as well as the various extension gap sizesbetween the tibia and the femur.

[0052] Referring now to FIGS. 3-6, the femoral mold 200, also referredto herein as a first mold, may comprise an arcuate surface 205, asidewall 202, an inner base surface 210 and an outer surface, generallyreferred to at 220. The inner base surface 210 and the sidewall 202 maydefine a cavity, sometimes referred to herein as a first cavity andgenerally referred to by item 230, which may be configured anddimensioned to receive an amount of biocompatible material, such as bonecement. It will be appreciated that the structural features providedherein, and the mold's 200 elastic characteristics, may be referred toherein as a means for attaching the mold, in situ, directly to thepatient's bone, wherein the means for attaching may be a circumferentialelastic gripping means for circumferentially gripping a proximal portionof the femur. As illustrated best in FIG. 5, the cavity 230 may becharacterized as having an open face 230 a for receiving the amount ofbiocompatible material, i.e. bone cement, which when cured will form thefemoral component 75 (illustrated best in FIG. 6). The femoral mold 200,having an open face 230 a, may further be characterized by the absenceof a substantially enclosed casing. It will be appreciated that theouter surface 220 may define the outer shape of the femoral mold 200,which may be any suitable outer shape for simulating, at least in part,the natural biomechanics of the knee joint, and particularly thebiomechanics of the patient's distal femur and femoral condyles.

[0053] A thickness “T” of the femoral mold 200 may be formed between thesidewall 202 and the outer surface 220. It should be noted that thethickness “T” may be altered to accommodate different design features orcharacteristics requiring a thicker or thinner wall thickness. It is tobe understood that any wall thickness of the femoral mold 200 of thepresent invention may be utilized by modifying the thickness “T” to beof any desired thickness to provide the desired amount of elasticity tothe mold 200.

[0054] The femoral mold 200 may have a main body portion 226 and two legportions, a first leg portion 222 and a second leg portion 224,extending generally from the main body portion 226 in a substantiallyarcuate manner, as illustrated. It will be appreciated that the firstleg portion 222 may be a medial leg 222, and the second leg portion 224may be a lateral leg 224. The medial leg 222 and the lateral leg 224 mayeach have an inner surface, designated as items 222 a and 224 a, and anouter surface, designated as items 222 b and 224 b, to form theresulting femoral condyles 82 and 84. The arcuate shape of the innersurface of the femoral mold 200 may result in rounded artificial femoralcondyles 82 and 84, which may be configured to articulate with thetibial component's 50 depressions 52 and 54 such that the naturalbiomechanics of the femoral condyles may be simulated, at least in part.A gap, generally referred to at 228, may separate the medial leg 222from the lateral leg 224. The gap 228 may be defined by a junctionbetween the two leg portions 222 and 224 forming a crotch 238, andallows the resulting femoral component 75 and its two condyles 82 and 84to straddle a raised portion 56 formed on the tibial component 50, whilearticulating with tibial depressions 52 and 54.

[0055] The articulation between the two artificial condyles 82 and 84 ofthe femoral component 75 and the corresponding surface of the tibialcomponent 50 is a feature that allows patients to bend their knees atthe joints, resulting in at least a limited range of motion. Thus, thetibial mold 100 and the femoral mold 200 may each have the capability toform implants that simulate, at least in part, the natural articulationsurfaces of the knee joint, so that patients may enjoy a limited rangeof motion in the knee joint, which advantageously provides the basis fora successful subsequent surgery.

[0056] The main body portion 226 may further comprise a first engagementside, generally referred to in FIG. 5 at 212, and a second engagementside, generally referred to in FIG. 5 at 214, each of which engages adifferent portion of the distal femur. A separation distance, referredto as item 216 in FIG. 4, may be formed between the first engagementside 212 and the second engagement side 214, and may be dimensioned tobe less than a width of the distal end of the femur, such that someelasticity in the femoral mold 200 may be required in order for the mold200 to stretch around or over a portion of the femur.

[0057] The cavity 230 of the femoral mold 200 may be further defined bythe sidewall 202, sometimes referred to herein as a first sidewall, thatmay extend around a perimeter 201 of the main body portion 226 of thefemoral mold 200. The sidewall 202 may comprise an edge 232, andsurrounds the cavity 230 such that the sidewall 202 aids in maintainingthe fixation material within the cavity 230 of the mold 200.Specifically, the sidewall 202 may function as a barrier and may providean upper surface or wall, where the bone cement or other suitablebiocompatible material may be poured into the cavity 230 and retainedwithin the cavity 230 by said sidewall 202.

[0058] It will be appreciated that an angular portion 234 may extendfrom the sidewall 202 to the outer surface 220 to connect the sidewall202 and the outer surface. It should be noted that angular portion 234may be rounded and may be configured for connecting the sidewall 202 tothe outer surface 220 and may include any size and shape in order toconnect the sidewall 202 to the outer surface 220.

[0059] The inner base surface 210 may have an inner contour thatproduces the femoral component 75 that has a resulting exterior contoursimulating, at least in part, the shape and function of the naturalfemoral condyles. It will be appreciated that the term “contour” as usedherein may refer to the surface of the mold 200 that produces thearticulating surface of the resulting component 75, whether thearticulating surface comprises a flat contour, a rounded contour, or ispartially contoured with protrusions, or depressions, or a combinationof both, or fully contoured with protrusions, or depressions, or acombination of both. Specifically, the lateral leg 222 and the medialleg 224 form the main articulating surfaces of the resulting femoralcomponent 75 and simulate, at least in part, the natural femoralcondyles. A protruding arched surface 236 may protrude from the innerbase surface 210, which may form a corresponding mild depression 80 inthe resulting femoral component 75, which depression 80 may be oneportion of the femoral component 75 that articulates with a portion ofthe tibial component 50.

[0060] An eyelet 270 may extend in an upward direction from the top ofthe femoral mold 200 for aiding the surgeon in wrapping the femoral mold200 around the distal femur and for further aiding in the separation ofthe femoral mold 200 from the femoral component 75. The eyelet 270 maybe shaped in as a loop with a rounded top 270 a and two ends 270 b and270 c connected to the main body portion 226, as illustrated in FIGS.4-6, or the eyelet 270 may have a square shape, an elongated shape, atriangular shape, a polygonal shape, or any other suitable shape foraiding the surgeon in locating the femoral mold 200 on the bone, andremoving said femoral mold 200 from the bone.

[0061] The femoral mold 200 may be configured and dimensioned such thatit may be wrapped around the distal femur or bone surface, even afterthe mold 200 has been substantially filled with biocompatible material.Wrapping the femoral mold 200 may result in the biocompatible material,which is maintained within the cavity 230 of the femoral mold 200 by thesidewall 202, mating with the distal femur to thereby adhere thebiocompatible material to the bone, forming the femoral component 75. Byso doing, the mold 200 may stretch around the distal femur, and theouter surface geometry of the distal femur may be closely matched due tothe stretching of the elastic mold 200 resulting in a properly sizedfemoral component 75 being formed on the bone, while simultaneouslysecurely fastening the femoral component 75 to the bone preventing anyunwanted movement.

[0062] The femoral mold 200 also has the ability to be peeled or tornoff once the bone cement has cured, due at least in part to theelasticity of the material from which the femoral mold 200 may becomprised. Additionally, the elasticity of the femoral mold 200 permitsthe mold to accommodate and be attached to a variety of distal femursizes. The elasticity of the material may be a feature in both thetibial mold 100 and the femoral mold 200.

[0063] Removal of the femoral mold 200 from the resulting femoralcomponent 75 may be accomplished by pulling the mold 200 off of thefemoral component 75 and femoral bone, or by scoring, cutting, tearing,ripping, splitting, trimming, peeling and otherwise pulling andmanipulating the elastic femoral mold 200 from the bone. Elasticity ofthe femoral mold 200 advantageously provides the capability for the mold200 to stretch and wrap around a bone during attachment. The elasticcapability, therefore, allows a single femoral mold 200 to accommodateand attach to many different sizes of distal femurs. Elasticity alsoprovides the capability for the femoral mold 200 to be easily separatedfrom the femoral component 75 and bone during removal.

[0064] The femoral mold 200, being elastic, may be constructed from asilicone or rubber material, and possesses elastic memory, which causesthe mold 200 to return to its original shape or position afterdistortion. Therefore, the elastic memory of the material may provideenough strength for the mold 200 to maintain its shape during theattachment of the femoral mold 200 to the femoral bone, and may also beflexible enough that one mold 200 may be used for several differentsizes of bone, while providing the ability to easily be pulled from offof the femoral component 75, or cut or torn from the femoral component75 without adversely affecting the component 75.

[0065] In practice, the femoral mold 200 may be used in situ by thesurgeon in the following manner. First, bone cement, or anotherbiocompatible material known in the art for temporary fabrication offemoral components 75, may be mixed and poured into the cavity 230 ofthe femoral mold 200. The surgeon may then scrape the edge 232 of thesidewall 202 with a knife or other appropriate instrument toappropriately pack and level the cement within the femoral mold 200.

[0066] Second, the bone cement located within the cavity 230 of thefemoral mold 200 may be allowed to cure slightly, after which thefemoral mold 200 may be located on the distal end of the femur, wherethe bone cement may be allowed to completely cure. During the locationprocess, the femoral mold 200 may be stretched and pressed firmly aroundthe distal portion of the bone so that a tight connection between thebone and the mold 200 may be formed. Additionally, the bone cement maycontact the surface of the bone causing the bone cement to adhere to thebone.

[0067] The elasticity of the material comprising the femoral mold 200permits the mold 200 to wrap around and attach to the distal femur byforcing the first engagement side 212 away from the second engagementside 214 such that the separation distance 216 may be enlargedmomentarily thereby allowing the mold 200 to be attached to the distalfemur. At this point, the elastic memory of the mold 200 causes thefirst engagement side 212 and the second engagement side 214 to returnsubstantially back to their original shape. The mold 200 may be,therefore, pressed onto the distal femur such that a secure, frictionfit between the mold 200 and the bone may be obtained. It will beappreciated that the term friction fit includes a press fit, acompression fit, an interference fit and the like.

[0068] Once the cement has completely cured and hardened, the surgeonmay remove the elastic femoral mold 200 by any one of a variety ofmethods, including pulling the mold 200 from off of the femoralcomponent 75, or cutting a portion of the mold 200 and tearing theremainder of the mold 200 away from the resulting femoral component 75,or simply using the eyelet 270 to pull or tear the mold 200 from thecomponent 75. Other examples of the methods of removal include: scoring,cutting, tearing, ripping, splitting, peeling and otherwise pulling themold 200 apart from said bone. The removal process acts as the last stepin forming the femoral component 75 on the bone. It will be appreciatedthat the removal of the femoral mold 200 may be accomplished by avariety of methods utilizing a variety of devices, each of which areintended to fall within the scope of the present invention.

[0069] It will be appreciated that the structure and apparatus disclosedherein is merely one example of a means for attaching the mold, in situ,directly to the bone, and it should be appreciated that any structure,apparatus or system for attaching the mold to the bone which performsfunctions the same as, or equivalent to, those disclosed herein areintended to fall within the scope of a means for attaching the mold tothe bone, including those structures, apparatus or systems for attachingthe mold to the bone which are presently known, or which may becomeavailable in the future. Anything which functions the same as, orequivalently to, a means for attaching the mold to the bone falls withinthe scope of this element.

[0070] In accordance with the features and combinations described above,a useful method of implanting a tibial mold 100 on a patient's kneejoint includes the steps of:

[0071] (a) providing an elastic tibial mold, said tibial mold having asidewall defining a cavity;

[0072] (b) determining a desired thickness of a tibial component of aknee replacement to fit a portion of an extension gap by measuring thedistance between the distal end of the femur and the proximal end of thetibia by utilizing a marking formed on an outer surface of the tibialmold;

[0073] (c) scoring the tibial mold at the level of the desired thicknessmarking and utilizing a depth ring as a guide for a cutting device,wherein said depth ring may at least partially circumscribe the tibialmold;

[0074] (d) removing the excess portion of the tibial mold such that onlythe desired thickness of the resulting tibial component may be formed;

[0075] (e) providing a biocompatible material, configured for use as thetibial component, and substantially filling the cavity of the tibialmold with said biocompatible material to the previously determinedthickness;

[0076] (f) positioning the tibial mold on the proximal end of the tibia;

[0077] (g) permitting the biocompatible material to at least partiallycure; and

[0078] (h) removing the tibial mold from the bone and the resultingtibial component.

[0079] In accordance with the features and combinations described above,a useful method of implanting a femoral mold 200 on a patient's kneejoint includes the steps of:

[0080] (a) providing an elastic femoral mold, said femoral mold having asidewall defining a cavity;

[0081] (b) providing a biocompatible material, configured for use as afemoral component, and substantially filling the cavity of the femoralmold with said biocompatible material to a desired thickness;

[0082] (c) positioning the femoral mold on the distal end of the femurby stretching and firmly wrapping the femoral mold around a distalportion of the femur;

[0083] (d) permitting the biocompatible material to at least partiallycure; and

[0084] (e) removing the femoral mold from the bone and the resultingfemoral component, including pulling, scoring, cutting, tearing andpeeling the femoral mold away from said bone and said femoral component.

[0085] Those having ordinary skill in the relevant art will appreciatethe advantages provided by the features of the present invention. Forexample, it is a potential feature of the present invention to provide adisposable knee mold system which is simple in design and manufacture.Another potential feature of the present invention is to provide such adisposable knee mold system that is elastic, and relatively inexpensiveto manufacture such that the molds may be used once and then disposedof, and modified to fit the anatomy of a particular patient. It is afurther potential feature of the present invention, in accordance withone aspect thereof, to provide a knee mold system that is manufacturedfrom an elastic material possessing elastic memory such that the moldmay be stretched and deformed in order to secure the mold to the bone ofthe knee joint, without maintaining such a deformed shape. It is afurther potential feature of the present invention to provide a kneemold system that permits the molds to be located on the bone, in situ,during surgery. It is yet another potential feature of the presentinvention to provide a knee mold system that comprises a femoral moldand a tibial mold, both of which may be formed as a unitary piece. It isanother potential feature of the present invention to provide a kneemold system that may accommodate varying anatomical differences within agiven range using a single tibial mold and a single femoral mold. It isstill another potential feature of the present invention to provide aknee mold system that may be located on the bone permitting theformation of an implant and then subsequently removed easily from thebone and implant by way of pulling, peeling, cutting, scoring andtearing the mold without adversely affecting the implant. It is anotherpotential feature of the present invention to provide a knee mold systemthat forms a resulting tibial implant and femoral implant that simulatethe biomechanics of the natural knee joint, at least in part, such thata patient may have some mobility and some range of motion in the kneejoint during the time period the temporary prosthetic implant is locatedwithin the knee joint and before the revision surgery.

[0086] It is to be understood that the above-described arrangements areonly illustrative of the application of the principles of the presentinvention. Numerous modifications and alternative arrangements may bedevised by those skilled in the art without departing from the spiritand scope of the present invention and the appended claims are intendedto cover such modifications and arrangements. Thus, while the presentinvention has been shown in the drawings and described above withparticularity and detail, it will be apparent to those of ordinary skillin the art that numerous modifications, including, but not limited to,variations in size, materials, shape, form, function and manner ofoperation, assembly and use may be made without departing from theprinciples and concepts set forth herein.

What is claimed is:
 1. An elastic mold for forming a prostheticcomponent of a prosthetic joint on a patient's bone, said elastic moldcomprising: a main body portion comprising a sidewall, an inner surfaceand an outer surface, the inner surface and the outer surface defining athickness of the sidewall therebetween; and a cavity defined by thesidewall, said sidewall extending around a perimeter of the main bodyportion, the cavity being formed within the main body portion of theelastic mold, wherein said cavity may be characterized by an open faceand configured for receiving an amount of biocompatible materialthereinto, said biocompatible material configured for being used as theprosthetic component; wherein said elastic mold may be configured anddimensioned for being located, in situ, on a portion of the patient'sbone; and wherein said elastic mold may be characterized by the absenceof a substantially enclosed casing.
 2. The elastic mold of claim 1,wherein said elastic mold comprises a tibial mold having an inner basesurface comprising at least one protrusion and at least one depressionconfigured for forming a corresponding and opposing at least onedepression and at least one protrusion in the prosthetic component suchthat a natural tibial plateau may be simulated.
 3. The elastic mold ofclaim 1, wherein said elastic mold comprises a tibial mold having aplurality of markings formed on the outer surface of the main bodyportion such that a surgeon may use the plurality of markings of thetibial mold as a guide.
 4. The elastic mold of claim 3, wherein saidplurality of markings comprise a series of symbols representing apredetermined size and thickness of the prosthetic component, and may beused for visually determining a thickness of bone cement for fittingbetween a gap in the patient's tibial bone and femoral bone.
 5. Theelastic mold of claim 1, wherein said elastic mold comprises a tibialmold having a plurality of depth rings for scoring, cutting, trimming,and peeling off an excess portion of the tibial mold, said plurality ofdepth rings comprising a series of indentations in the outer surface ofthe main body portion configured for running an instrument in saidplurality of depth rings such that the series of indentations acts as aguide.
 6. The elastic mold of claim 1, wherein said elastic moldcomprises a tibial mold having an external shape defined by the outersurface of the main body portion, wherein said external shape may besubstantially kidney shaped and corresponds to a cross sectional shapeof the natural tibial bone.
 7. The elastic mold of claim 1, wherein saidelastic mold comprises a tibial mold that may be configured anddimensioned for forming a resulting prosthetic tibial component havingan articulating surface for articulation with a corresponding surface ofa prosthetic femoral component.
 8. The elastic mold of claim 1, whereinsaid elastic mold comprises a femoral mold having an eyelet shaped as aloop with a rounded top, and a first end and a second end connected tothe main body portion, the eyelet being configured for aiding a surgeonin wrapping the femoral mold around a distal portion of a femur and forfurther aiding in the separation of the femoral mold from a resultingprosthetic femoral component.
 9. The elastic mold of claim 1, whereinsaid elastic mold comprises a femoral mold, and wherein said sidewallextends around a perimeter of the main body portion, and said sidewallmay be configured to provide a barrier such that an amount ofbiocompatible material, configured for use as the prosthetic component,may be poured into the cavity and retained within said cavity by saidsidewall.
 10. The elastic mold of claim 1, wherein said elastic moldcomprises a femoral mold having a protruding arched surface located on aportion of said inner surface configured and dimensioned for forming acorresponding depression in a prosthetic femoral component.
 11. Theelastic mold of claim 1, wherein said elastic mold comprises a femoralmold having a main body portion, a medial leg and a lateral leg, eachleg having a substantially arcuate inner surface designed to form aprosthetic femoral condyle to simulate the biomechanics of the naturalfemoral condyle such that the prosthetic femoral condyle may articulatewith a tibial surface.
 12. The elastic mold of claim 11, wherein saidfemoral mold has a gap formed between the medial leg and the lateralleg, wherein the medial leg joins the lateral leg at a junction, saidjunction defining a crotch portion of the main body portion.
 13. Theelastic mold of claim 1, wherein said elastic mold comprises a femoralmold, said femoral mold being manufactured from an elastic material thatmay be substantially filled with an amount of biocompatible materialsuch that the femoral mold may be wrapped around a portion of thepatient's femur to bring the biocompatible material into contact with asurface of a portion of the femur, wherein said elastic material permitsthe femoral mold to stretch, allowing a single femoral mold toaccommodate various sizes of bone and also aids in removing the femoralmold from the femur.
 14. The elastic mold of claim 1, wherein saidelastic mold comprises a femoral mold configured and dimensioned to forma resulting prosthetic femoral component having an articulating surfacefor articulation with a corresponding surface of a prosthetic tibialcomponent.
 15. The elastic mold of claim 14, wherein the resultingprosthetic femoral component comprises a plurality of protrudingsurfaces dimensioned to simulate the natural femoral condyles.
 16. Theelastic mold of claim 1, wherein the mold may be manufactured from anelastic material that may be designed for being used once and thendisposed of such that a surgeon may alter and adjust the mold toaccommodate an anatomy of the patient.
 17. The elastic mold of claim 1,wherein the mold may be a femoral mold having a first engagement sideand a second engagement side, each engagement side configured forengaging a portion of the patient's femur, and a separation distanceformed between the first engagement side and the second engagement side,wherein the separation distance between the first engagement side andthe second engagement side may be dimensioned to be less than a width ofa distal end of the patient's femur such that a secure fit may be formedbetween the patient's femur and the mold, due, at least in part, to theelasticity of the mold.
 18. An elastic mold for forming a prostheticcomponent on a patient's femur, said elastic mold comprising: a mainbody portion having a first engagement side and a second engagementside, each engagement side configured for engaging a portion of thepatient's femur, the main body portion further having a sidewall, aninner surface and an outer surface, the inner surface and the outersurface defining a thickness of the elastic mold therebetween; a cavitydefined by the sidewall and the inner surface and formed within the mainbody portion, the cavity having an open face, the elastic mold beingfurther characterized by the absence of a substantially enclosed casing;and a separation distance formed between the first engagement side andthe second engagement side, wherein the separation distance between thefirst engagement side and the second engagement side may be dimensionedto be less than a width of a distal end of the femur such that a securefit may be formed between the femur and the mold, due, at least in part,to the elasticity of the mold.
 19. The elastic mold of claim 18, whereinsaid elastic mold comprises a femoral mold having an eyelet for aiding asurgeon in wrapping the femoral mold around a distal portion of thefemur and for further aiding in the separation of the femoral mold fromthe femur and a resulting prosthetic femoral component located on saidfemur.
 20. The elastic mold of claim 18, wherein said elastic moldcomprises a femoral mold, and wherein said sidewall extends around aperimeter of the main body portion, and said sidewall may be configuredto provide a barrier such that an amount of biocompatible material,configured for use as the prosthetic component, may be poured into thecavity and retained within said cavity by said sidewall.
 21. The elasticmold of claim 18, wherein said elastic mold comprises a femoral moldhaving a protruding arched surface located on a portion of said innersurface for forming a corresponding depression in a prosthetic femoralcomponent.
 22. The elastic mold of claim 18, wherein said elastic moldcomprises a femoral mold having a medial leg and a lateral leg, each leghaving a substantially arcuate inner surface configured to form aprosthetic femoral condyle that may be dimensioned to simulate thebiomechanics of the natural femoral condyles.
 23. The elastic mold ofclaim 22, wherein said femoral mold further comprises a gap formedbetween and separating the medial leg and the lateral leg, wherein themedial leg joins the lateral leg at a junction, said junction defining acrotch portion of the main body portion.
 24. The elastic mold of claim18, wherein said elastic mold comprises a femoral mold that may bemanufactured from an elastic material and being substantially filledwith an amount of biocompatible material such that the femoral mold maybe wrapped around a portion of the patient's femur to bring thebiocompatible material into engagement with a surface of a portion ofthe femur, wherein said elastic material permits the femoral mold tostretch, allowing a single femoral mold to accommodate various sizes ofdistal femurs and for peeling the femoral mold away from the femur aftersaid mold may be scored.
 25. The elastic mold of claim 18, wherein saidelastic mold comprises a femoral mold that forms a resulting prostheticfemoral component having an articulating surface for articulation with acorresponding surface of a prosthetic tibial component.
 26. The elasticmold of claim 25, wherein the resulting prosthetic femoral componentcomprises a plurality of protruding surfaces such that the naturalfemoral condyles may be simulated by said protruding surfaces.
 27. Theelastic mold of claim 18, wherein the mold may be manufactured from anelastic material that may be designed for being used once and thendisposed of such that a surgeon may alter and adjust the mold toaccommodate an anatomy of the patient.
 28. An elastic mold for forming aprosthetic component on a patient's femur, said elastic mold comprising:a main body portion having an inner surface and an outer surface, saidinner surface and said outer surface defining a thickness of the elasticmold therebetween; a cavity defined at least partially by the innersurface and formed within the main body portion, said cavity beingcharacterized by an open face; and a means for attaching the elasticmold, in situ, to the patient's femur such that the elastic mold mayform the prosthetic component on said femur, wherein the prostheticcomponent simulates, at least in part, the biomechanics of a naturalknee joint; wherein the elastic mold may be characterized by the absenceof a substantially enclosed casing.
 29. The elastic mold of claim 28,wherein said elastic mold comprises a femoral mold having an eyelet foraiding a surgeon in stretching and wrapping the femoral mold around adistal portion of the femur, and for further aiding in the separation ofthe femoral mold from a resulting prosthetic femoral component.
 30. Theelastic mold of claim 28, wherein said elastic mold comprises a femoralmold, and wherein said means for attaching the elastic mold comprises acircumferential elastic gripping means for circumferentially gripping aproximal portion of the femur.
 31. The elastic mold of claim 28, whereinsaid elastic mold comprises a femoral mold, and wherein said means forattaching the elastic mold comprises a sidewall that extends around aperimeter of the main body portion, said sidewall configured to providea barrier such that an amount of biocompatible material, configured foruse as the prosthetic component, may be poured into the cavity andretained within said cavity by said sidewall.
 32. The elastic mold ofclaim 28, wherein said elastic mold comprises a femoral mold having aprotruding arched surface located on a portion of said inner surface forforming a corresponding depression in a prosthetic femoral component.33. The elastic mold of claim 28, wherein said elastic mold comprises afemoral mold having a medial leg and a lateral leg, each leg having asubstantially arcuate inner surface configured to form a prostheticfemoral condyle that may be dimensioned to simulate the biomechanics ofthe natural femoral condyle.
 34. The elastic mold of claim 33, whereinsaid femoral mold further comprises a gap formed between and separatingthe medial leg and the lateral leg, wherein the medial leg joins thelateral leg at a junction, said junction defining a crotch portion ofthe main body portion.
 35. The elastic mold of claim 28, wherein saidelastic mold comprises a femoral mold that may be manufactured from anelastic material and being substantially filled with an amount ofbiocompatible material such that the femoral mold may be wrapped arounda portion of the patient's femur to bring the biocompatible materialinto engagement with a surface of a portion of the femur, wherein saidelastic material permits the femoral mold to stretch, allowing a singlefemoral mold to accommodate various sizes of distal femurs and to aid asurgeon in peeling the femoral mold away from the femur and resultingprosthetic femoral component.
 36. The elastic mold of claim 28, whereinsaid elastic mold comprises a femoral mold configured to form aresulting prosthetic femoral component having an articulating surfacefor articulation with a corresponding surface of a prosthetic tibialcomponent.
 37. The elastic mold of claim 36, wherein the resultingprosthetic femoral component comprises a plurality of protrudingsurfaces configured and dimensioned to simulate the biomechanics of thenatural femoral condyles.
 38. The elastic mold of claim 28, wherein themold may be manufactured from an elastic material that may be designedfor being used once and then disposed of such that a surgeon may alterand adjust the mold to accommodate an anatomy of the patient.
 39. Theelastic mold of claim 28, wherein the mold may have a first engagementside and a second engagement side, each engagement side configured forengaging a portion of the patient's femur, and a separation distanceformed between the first engagement side and the second engagement side,wherein the separation distance between the first engagement side andthe second engagement side may be dimensioned to be less than a width ofa distal end of the patient's femur such that a secure fit may be formedbetween the patient's femur and the mold, due, at least in part, to theelasticity of the mold.
 40. An elastic mold for forming a prostheticcomponent on a patient's bone, said elastic mold comprising: a main bodyportion comprising an inner surface and an outer surface, said innersurface and said outer surface defining a thickness of the elastic moldtherebetween; a cavity defined by a sidewall and the inner surface, thecavity being formed within the main body portion of the elastic mold,said inner surface having a protruding arched surface located on aportion of said inner surface; wherein said protruding arched surfaceforms a depression in an articulating surface of the resultingprosthetic component for articulating with another component between twobones.
 41. The elastic mold of claim 40, wherein said elastic moldcomprises a femoral mold having an eyelet for aiding a surgeon instretching and wrapping the femoral mold around a distal portion of afemur, and for further aiding the surgeon in separating the femoral moldfrom a resulting prosthetic femoral component and femur after use. 42.The elastic mold of claim 40, wherein said elastic mold comprises afemoral mold, and wherein the sidewall forming the cavity extends arounda perimeter of the main body portion, and said sidewall being configuredto provide a barrier such that an amount of biocompatible material,configured for use as the prosthetic component, may be poured into thecavity and retained within said cavity by said sidewall.
 43. The elasticmold of claim 40, wherein said elastic mold comprises a femoral mold,wherein the main body portion has a medial leg and a lateral leg, eachleg having a substantially arcuate inner surface configured to form aprosthetic femoral condyle that may be dimensioned to simulate thebiomechanics of the natural femoral condyle.
 44. The elastic mold ofclaim 43, wherein said femoral mold further comprises a gap formedbetween and separating the medial leg and the lateral leg, wherein themedial leg joins the lateral leg at a junction, said junction defining acrotch portion of the main body portion.
 45. The elastic mold of claim40, wherein said elastic mold comprises a femoral mold that may bemanufactured from an elastic material and substantially filled with anamount of biocompatible material such that the femoral mold may bewrapped around a portion of a patient's femur to bring the biocompatiblematerial into contact with a surface of a portion of the femur, whereinsaid elastic material permits the femoral mold to stretch, allowing asingle femoral mold to accommodate various sizes of distal femurs andfor peeling the femoral mold away from the femur and a resultingcomponent.
 46. The elastic mold of claim 40, wherein said elastic moldcomprises a femoral mold configured for forming a resulting prostheticfemoral component having an articulating surface for articulation with acorresponding surface of a prosthetic tibial component.
 47. The elasticmold of claim 46, wherein the femoral mold comprises a rounded contourformed in the inner surface of the main body portion such that theresulting prosthetic femoral component comprises a plurality ofprotruding surfaces configured and dimensioned to simulate the naturalfemoral condyles.
 48. The elastic mold of claim 40, wherein the mold maybe manufactured from an elastic material that may be designed for beingused once and then disposed of such that a surgeon may alter and adjustthe mold to accommodate an anatomy of the patient.
 49. The elastic moldof claim 40, wherein the mold may have a first engagement side and asecond engagement side, each engagement side configured for engaging aportion of the patient's femur, and a separation distance formed betweenthe first engagement side and the second engagement side, wherein theseparation distance between the first engagement side and the secondengagement side may be dimensioned to be less than a width of a distalend of the patient's femur such that a secure fit may be formed betweenthe patient's femur and the mold, due, at least in part, to theelasticity of the mold.
 50. An elastic mold for forming a prostheticcomponent on a patient's bone, said elastic mold comprising: a main bodyportion comprising a sidewall and having an inner surface and an outersurface, said inner surface and said outer surface defining a thicknessof the elastic mold therebetween, said main body portion furthercomprising an arcuate surface; a cavity defined by the sidewall andformed within the main body portion of the elastic mold; a first leg anda second leg each having a substantially arcuate inner surfaceconfigured to form a prosthetic femoral condyle, the prosthetic femoralcondyle configured and dimensioned to simulate the biomechanics of anatural femoral condyle; and a gap formed between and separating thefirst leg and the second leg wherein the first leg joins the second legat a junction, said junction defining a crotch portion of the main bodyportion.
 51. The elastic mold of claim 50, wherein said elastic moldcomprises a femoral mold having an eyelet for aiding a surgeon instretching and wrapping the femoral mold around a distal portion of afemur, and for further aiding the surgeon in separating the femoral moldfrom a resulting prosthetic femoral component and femur.
 52. The elasticmold of claim 50, wherein said elastic mold comprises a femoral mold,and wherein said sidewall extends around a perimeter of the main bodyportion, and said sidewall may be configured to provide a barrier suchthat an amount of biocompatible material, configured for use as theprosthetic component, may be poured into the cavity and retained withinsaid cavity by said sidewall.
 53. The elastic mold of claim 50, whereinsaid elastic mold comprises a femoral mold having a protruding archedsurface located on a portion of said inner surface of said main bodyportion for forming a corresponding depression in a prosthetic femoralcomponent.
 54. The elastic mold of claim 50, wherein said elastic moldcomprises a femoral mold, and wherein said first leg may be located on amedial side of a distal end of a femur and said second leg may belocated on a lateral side of the distal end of the femur.
 55. Theelastic mold of claim 50, wherein said elastic mold comprises a femoralmold, said femoral mold being manufactured from an elastic material andsubstantially filled with an amount of biocompatible material such thatthe femoral mold may be wrapped around a portion of a patient's femur tothereby bring the biocompatible material into engagement with a surfaceof the portion of the femur, wherein said elastic material permits thefemoral mold to stretch, allowing a single femoral mold to accommodatevarious sizes of distal femurs and for peeling the femoral mold awayfrom the femur.
 56. The elastic mold of claim 50, wherein said elasticmold comprises a femoral mold, wherein said femoral mold forms aresulting prosthetic femoral component having an articulating surfacefor articulation with a corresponding surface of a prosthetic tibialcomponent.
 57. The elastic mold of claim 56, wherein the resultingprosthetic femoral component comprises a plurality of protrudingsurfaces simulating the natural femoral condyles.
 58. The elastic moldof claim 50, wherein the mold may be manufactured from an elasticmaterial that may be designed for being used once and then disposed ofsuch that a surgeon may alter and adjust the mold to accommodate ananatomy of the patient.
 59. The elastic mold of claim 50, wherein themold may have a first engagement side and a second engagement side, eachengagement side configured for engaging a portion of the patient'sfemur, and a separation distance formed between the first engagementside and the second engagement side, wherein the separation distancebetween the first engagement side and the second engagement side may bedimensioned to be less than a width of a distal end of the patient'sfemur such that a secure fit may be formed between the patient's femurand the mold, due, at least in part, to the elasticity of the mold. 60.A device for forming a temporary prosthetic component on a patient'stibia, the device comprising: a mold comprised of an elastic material,the elastic material comprising an elastic memory such that the mold mayalso comprise an elastic memory, the mold including: a main body portionhaving a cavity formed therein, said cavity being defined, at leastpartially, by an inner surface; a depth reference feature for aiding asurgeon in making a depth measurement such that the prosthetic componentmay be increased or decreased to fit a portion of a gap between thepatient's tibia and femur; and a means for attaching the mold, in situ,directly to the patient's tibia such that the mold may attach to saidtibia to form the prosthetic component on said tibia to therebysimulate, at least in part, a natural surface of a tibial plateau. 61.The device for forming a temporary prosthetic component of claim 60,wherein said mold comprises a tibial mold having an inner base surfacewith at least one protrusion and at least one depression configured forforming a corresponding set of at least one depression and at least oneprotrusion in the prosthetic component such that the inner base surfacecreates a the prosthetic implant that simulates, at least in part, thenatural surface of the tibial plateau.
 62. The device for forming atemporary prosthetic component of claim 60, wherein said mold comprisesa tibial mold, and said depth reference feature further comprises aplurality of markings formed on the outer surface of the main bodyportion such that a surgeon may use the plurality of markings of thetibial mold as a guide for visually determining a thickness of abiocompatible material needed to create the prosthetic component, whichmay be fitted in the gap formed between the patient's tibia and femur.63. The device for forming a temporary prosthetic component of claim 62,wherein said plurality of markings comprise a series of symbolsrepresenting a predetermined size and thickness corresponding to theprosthetic component.
 64. The device for forming a temporary prostheticcomponent of claim 60, wherein said mold comprises a tibial mold, andsaid at least one groove comprises a plurality of grooves that make up aplurality of depth rings that extend at least partially around an outersurface of the main body portion for scoring, cutting and peeling off anexcess portion of the tibial mold, and for running an instrument in saidplurality of depth rings, which act as a guide.
 65. The device forforming a temporary prosthetic component of claim 60, wherein said moldcomprises a tibial mold having an external shape defined by an outersurface of the main body portion, wherein said external shape may besubstantially kidney shaped and corresponds to a cross sectional shapeof the natural tibial bone.
 66. The device for forming a temporaryprosthetic component of claim 61, wherein the inner base surface withthe at least one protrusion comprises two protrusions located laterallyof the at least one depression, and the at least one depression may beformed in a central location of the inner base surface such that theprosthetic component may be formed with an articulating surface thatarticulates with a corresponding surface of a prosthetic femoralcomponent.
 67. The device for forming a temporary prosthetic componentof claim 60, wherein the mold may be designed for being used once andthen disposed of such that a surgeon may alter and adjust the mold, dueto the elastic material, to accommodate an anatomy of the patient. 68.The device for forming a temporary prosthetic component of claim 60,wherein the depth reference feature has at least one groove formed inthe main body portion.
 69. The device for forming a temporary prostheticcomponent of claim 60, wherein the depth reference feature has at leastone protrusion formed in the main body portion.
 70. The device forforming a temporary prosthetic component of claim 60, wherein the moldmay be characterized by the absence of a substantially enclosed casing.71. The device for forming a temporary prosthetic component of claim 60,wherein the means for attaching may be a circumferential elasticcontacting means for circumferentially contacting a proximal portion ofthe tibia.
 72. A device for forming a temporary prosthetic component ona bone of a patient's knee joint, said device comprising: a moldcomprised of an elastic material and substantially filled with abiocompatible material such that the mold may be stretched around aportion of the bone, in situ, and configured to wrap around the portionof the bone to thereby bring the biocompatible material into contactwith a surface of said portion of the bone, said mold furthercomprising: a main body portion comprising a sidewall, an inner surfaceand an outer surface, the inner surface and the outer surface defining athickness of the mold therebetween; and a cavity defined by the sidewalland the inner surface, wherein the cavity may be configured anddimensioned for receiving an amount of biocompatible material therein;wherein said mold may be manufactured as a single, unitary piece ofelastic material that may stretch and fit over a variety of bone sizes,and said mold being removable from the bone and prosthetic component,due, at least in part, to the elasticity of the material from which themold may be manufactured, by scoring, cutting, and peeling the mold. 73.The device for forming a temporary prosthetic component of claim 72,wherein said mold comprises a tibial mold that comprises an inner basesurface with at least one protrusion and at least one depressionthereon, wherein said base surface may be configured for forming acorresponding set of at least one depression and at least one protrusionin the prosthetic component such that a natural tibial plateau may besimulated, at least in part.
 74. The device for forming a temporaryprosthetic component of claim 72, wherein said mold comprises a tibialmold having a plurality of markings formed on the outer surface of themain body portion such that a surgeon may use the plurality of markingsas a guide for visually determining a thickness of bone cement to befitted in a gap between the patient's tibial bone and femoral bone. 75.The device for forming a temporary prosthetic component of claim 74,wherein said plurality of markings comprise a series of symbolsrepresenting a predetermined size and thickness of the prostheticcomponent.
 76. The device for forming a temporary prosthetic componentof claim 72, wherein said mold comprises a tibial mold having aplurality of depth rings for scoring, cutting and peeling off an excessportion of the tibial mold, said plurality of depth rings comprising aseries of indentations in the outer surface of the main body portionconfigured for running an instrument in said plurality of depth ringssuch that the series of indentations acts as a guide.
 77. The device forforming a temporary prosthetic component of claim 72, wherein said moldcomprises a tibial mold having an external shape defined by the outersurface of the main body portion, wherein said external shape may besubstantially kidney shaped and corresponds to a cross sectional shapeof a natural tibial bone.
 78. The device for forming a temporaryprosthetic component of claim 72, wherein said mold comprises a tibialmold that may be configured to form a resulting prosthetic tibialcomponent having an articulating surface to articulate with acorresponding surface of a prosthetic femoral component.
 79. The devicefor forming a temporary prosthetic component of claim 72, wherein saidmold comprises a femoral mold having an eyelet for aiding a surgeon inwrapping the femoral mold around a distal portion of a femur and forfurther aiding the surgeon in separating the femoral mold from aresulting prosthetic femoral component and femur.
 80. The device forforming a temporary prosthetic component of claim 72, wherein said moldcomprises a femoral mold, and wherein said sidewall extends around aperimeter of the main body portion, and said sidewall may be configuredto provide a barrier such that the amount of the biocompatible material,configured for use as the prosthetic component, may be poured into thecavity and retained within said cavity by said sidewall.
 81. The devicefor forming a temporary prosthetic component of claim 72, wherein saidmold comprises a femoral mold having a protruding arched surface locatedon a portion of said inner surface for forming a correspondingdepression in a prosthetic femoral component.
 82. The device for forminga temporary prosthetic component of claim 72, wherein said moldcomprises a femoral mold having a medial leg and a lateral leg, each leghaving a substantially arcuate inner surface configured to form aprosthetic femoral condyle that may be dimensioned to simulate thebiomechanics of a natural femoral condyle.
 83. The device for forming atemporary prosthetic component of claim 72, wherein said mold comprisesa femoral mold having a gap formed between and separating a medial legand a lateral leg, wherein the medial leg joins the lateral leg at ajunction, said junction defining a crotch portion of the main bodyportion.
 84. The device for forming a temporary prosthetic component ofclaim 72, wherein said mold comprises a femoral mold that may beconfigured to form a resulting prosthetic femoral component having anarticulating surface to articulate with a corresponding surface of aprosthetic tibial component.
 85. The device for forming a temporaryprosthetic component of claim 84, wherein the resulting prostheticfemoral component comprises a plurality of protruding surfaces thatsimulate natural femoral condyles.
 86. The device for forming atemporary prosthetic component of claim 72, wherein the mold may bemanufactured from an elastic material that may be designed for beingused once and then disposed of such that a surgeon may alter and adjustthe mold to accommodate an anatomy of the patient.
 87. The device forforming a temporary prosthetic component of claim 72, wherein the moldmay be a femoral mold having a first engagement side and a secondengagement side, each engagement side configured for engaging a portionof the patient's femur, and a separation distance formed between thefirst engagement side and the second engagement side, wherein theseparation distance between the first engagement side and the secondengagement side may be dimensioned to be less than a width of a distalend of the patient's femur such that a secure fit may be formed betweenthe patient's femur and the mold, due, at least in part, to theelasticity of the mold.
 88. An elastic mold for forming a prostheticcomponent on a patient's femur, said elastic mold comprising: a mainbody portion comprising a sidewall, an inner surface and an outersurface, said inner surface and said outer surface defining a thicknessof the elastic mold therebetween; and a cavity defined by the sidewalland the inner surface, and formed within the main body portion of theelastic mold; wherein said elastic mold may be manufactured in a unitarypiece such that the unitary elastic mold forms one complete prostheticcomponent to attach to the patient's femur, and wherein said elasticmold may be configured and dimensioned to be located, in situ, on thepatient's femur.
 89. The elastic mold of claim 88, wherein said elasticmold comprises a femoral mold having an eyelet for aiding a surgeon instretching and wrapping the femoral mold around a distal portion of thefemur, and for further aiding the surgeon in separating the femoral moldfrom the resulting prosthetic femoral implant and femur.
 90. The elasticmold of claim 88, wherein said elastic mold comprises a femoral mold,and wherein said sidewall extends around a perimeter of the main bodyportion, and said sidewall may be configured to provide a barrier suchthat an amount of biocompatible material, configured for use as theprosthetic component, may be poured into the cavity and retained withinsaid cavity by said sidewall.
 91. The elastic mold of claim 88, whereinsaid elastic mold comprises a femoral mold having a protruding archedsurface located on a portion of said inner surface for forming acorresponding depression in the femoral implant.
 92. The elastic mold ofclaim 88, wherein said elastic mold comprises a femoral mold, and saidmain body portion comprises a first leg that may be located on a medialside of a distal end of the femur and a second leg that may be locatedon a lateral side of the distal end of the femur.
 93. The elastic moldof claim 88, wherein said elastic mold comprises a femoral mold that maybe manufactured from an elastic material and substantially filled withan amount of biocompatible material such that the femoral mold may bewrapped around a distal portion of the patient's femur to bring thebiocompatible material into engagement with a surface of the distalportion of the femur, wherein said elastic material permits the femoralmold to stretch, allowing a single femoral mold to accommodate varioussizes of distal femurs and for peeling the femoral mold away from thefemur and the prosthetic component.
 94. The elastic mold of claim 88,wherein said elastic mold comprises a femoral mold that may beconfigured to form the resulting prosthetic component having anarticulating surface to articulate with a corresponding surface of aprosthetic tibial component.
 95. The elastic mold of claim 88, whereinthe resulting prosthetic component has a plurality of protrudingsurfaces simulating natural femoral condyles.
 96. The elastic mold ofclaim 88, wherein the mold may be manufactured from an elastic materialthat may be designed for being used once and then disposed of such thata surgeon may alter and adjust the mold to accommodate an anatomy of thepatient.
 97. The elastic mold of claim 88, wherein the mold may have afirst engagement side and a second engagement side, each engagement sideconfigured for engaging a portion of the patient's femur, and aseparation distance formed between the first engagement side and thesecond engagement side, wherein the separation distance between thefirst engagement side and the second engagement side may be dimensionedto be less than a width of a distal end of the patient's femur such thata secure fit may be formed between the patient's femur and the mold,due, at least in part, to the elasticity of the mold.
 98. An elasticmold system for forming a prosthetic component in a patient's kneejoint, said elastic mold system comprising: an elastic femoral moldconfigured for attachment to a distal end of the patient's femoral bone,and further configured for forming a first portion of the prostheticcomponent with an exterior contour dimensioned to simulate naturalfemoral condyles of the femur; a first cavity defined by a firstsidewall of the femoral mold, wherein the cavity comprises an open face,and wherein the femoral mold may be further characterized by an absenceof a substantially enclosed casing; and an elastic tibial moldconfigured for attachment to a proximal end of the patient's tibial bonefor forming a second portion of the prosthetic component, said secondportion having an exterior contour that simulates, at least partially, anatural tibial plateau; wherein said elastic tibial mold comprises asecond cavity defined by a second sidewall, and a depth referencefeature located on the second sidewall for making a depth determinationand for scoring and cutting away a portion of the elastic tibial mold.99. The elastic mold system of claim 98, wherein said tibial moldfurther comprises an inner base surface with at least one protrusion andat least one depression thereon configured for forming a correspondingset of at least one depression and at least one protrusion in the secondportion of the prosthetic component such that the natural tibial plateaumay be simulated, at least in part.
 100. The elastic mold system ofclaim 98, wherein said tibial mold comprises a main body portion and anouter surface, and said depth reference feature comprises a plurality ofmarkings formed on the outer surface such that a surgeon may use theplurality of markings of the tibial mold as a guide for visuallydetermining a thickness of bone cement to be fitted in a gap between apatient's tibial bone and femoral bone.
 101. The elastic mold system ofclaim 100, wherein said plurality of markings comprise a series ofsymbols representing a predetermined size and thickness of the secondportion of the prosthetic component.
 102. The elastic mold system ofclaim 98, wherein said tibial mold comprises a plurality of depth ringsfor scoring, cutting and peeling off an excess portion of the tibialmold, said plurality of depth rings comprising a series of indentationsin the outer surface of the main body portion configured for running aninstrument therein such that the series of indentations acts as a guide.103. The elastic mold system of claim 98, wherein said tibial moldcomprises a main body portion and an outer surface defining an externalshape of the tibial mold, wherein said external shape may besubstantially kidney shaped and corresponds to a cross sectional shapeof a natural tibial bone.
 104. The elastic mold system of claim 98,wherein said tibial mold may be configured to form a resultingprosthetic tibial component having an articulating surface to articulatewith a corresponding surface of a prosthetic femoral component.
 105. Theelastic mold system of claim 98, wherein said femoral mold comprises aneyelet for aiding a surgeon in wrapping the femoral mold around a distalportion of a femur and for further aiding the surgeon in separating thefemoral mold from a resulting prosthetic femoral component.
 106. Theelastic mold system of claim 105, wherein said eyelet may be formed onan end of the femoral mold.
 107. The elastic mold system of claim 98,wherein said femoral mold comprises a main body portion, an outersurface, wherein said first sidewall extends around a perimeter of themain body portion, said first sidewall configured to provide a barriersuch that an amount of biocompatible material, configured for use as theprosthetic component, may be poured into the first cavity and retainedwithin said first cavity by said first sidewall.
 108. The elastic moldsystem of claim 98, wherein said femoral mold comprises an inner surfaceand an outer surface, said femoral mold further comprises a protrudingarched surface located on a portion of said inner surface for forming acorresponding depression in the first portion of the prostheticcomponent.
 109. The elastic mold system of claim 98, wherein saidfemoral mold comprises a main body portion, a medial leg and a lateralleg, each leg having a substantially arcuate inner surface configured toform a prosthetic femoral condyle that may be dimensioned to simulatethe biomechanics of the natural femoral condyle.
 110. The elastic moldsystem of claim 98, wherein said femoral mold further comprises a mainbody portion and a gap formed between and separating the medial leg andthe lateral leg, wherein the medial leg joins the lateral leg at ajunction, said junction defining a crotch portion of the main bodyportion.
 111. The elastic mold system of claim 98, wherein said femoralmold may be manufactured from an elastic material and substantiallyfilled with an amount of biocompatible material such that the femoralmold may be wrapped around a portion of a patient's femur to bring thebiocompatible material into engagement with a surface of a portion ofthe femur, wherein said elastic material permits the femoral mold tostretch, allowing a single femoral mold to accommodate various sizes offemoral bone and for peeling the femoral mold away from the femur. 112.The elastic mold system of claim 98, wherein the femoral mold and thetibial mold are both manufactured from an elastic material that may bedesigned for being used once and then disposed of such that a surgeonmay alter and adjust the mold to accommodate an anatomy of the patient.113. A method of forming at least one component of a temporaryprosthetic knee joint on a bone during an in situ surgical procedure,the method comprising the steps of: providing an elastic mold configuredand dimensioned for being affixed to a portion of the bone, said elasticmold having a cavity defined by a sidewall; placing an amount ofbiocompatible material within the cavity of the elastic mold for formingthe at least one component of the prosthetic knee joint; positioning theelastic mold on the portion of the bone; and removing the elastic moldfrom said portion of said bone after the amount of biocompatiblematerial has been at least partially cured thereby forming said at leastone component.
 114. The method of forming at least one component of atemporary prosthetic knee joint of claim 113, wherein the step ofproviding an elastic mold further comprises providing an elastic femoralmold that may be characterized by the absence of a substantiallyenclosed casing.
 115. The method of forming at least one component of atemporary prosthetic knee joint of claim 113, wherein the step ofproviding an elastic mold further comprises providing an elastic femoralmold having a protruding arched surface on an interior surface thatforms a depression in a resulting femoral prosthesis.
 116. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of providing an elastic mold furthercomprises providing an elastic femoral mold, wherein said cavity may becharacterized by an open face.
 117. The method of forming at least onecomponent of a temporary prosthetic knee joint of claim 113, wherein thestep of providing an elastic mold further comprises providing an elasticfemoral mold, wherein the femoral mold has an eyelet for aiding asurgeon in wrapping the femoral mold around a distal portion of a femurand for further aiding in the removal of said femoral mold by separatingthe femoral mold from a resulting femoral prosthesis.
 118. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of providing an elastic mold furthercomprises providing an elastic femoral mold, wherein the sidewallextends around a perimeter of the femoral mold, and said sidewall may beconfigured to provide a barrier such that the biocompatible material maybe retained within said cavity by said sidewall.
 119. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of providing an elastic mold furthercomprises providing an elastic femoral mold, wherein the femoral moldhas a main body portion, a medial leg and a lateral leg, each leg havinga substantially arcuate inner surface designed to form a prostheticfemoral condyle to simulate, at least in part, the biomechanics of thenatural femoral condyle such that the prosthetic femoral condyle mayarticulate with a tibial surface.
 120. The method of forming at leastone component of a temporary prosthetic knee joint of claim 119, whereinthe step of providing the elastic mold comprises providing the femoralmold with a gap formed between the medial leg and the lateral leg,wherein the medial leg joins the lateral leg at a junction, saidjunction defining a crotch portion of the main body portion.
 121. Themethod of forming at least one component of a temporary prosthetic kneejoint of claim 113, wherein the step of providing an elastic moldfurther comprises providing an elastic femoral mold, wherein the femoralmold may be manufactured from an elastic material such that the femoralmold may be wrapped around a distal portion of a patient's femur tobring the biocompatible material into contact with a surface of thedistal portion of the femur, wherein said elastic material permits thefemoral mold to stretch, allowing a single femoral mold to accommodatevarious distal femur sizes, and also aids a surgeon in removing thefemoral mold from the femur.
 122. The method of forming at least onecomponent of a temporary prosthetic knee joint of claim 113, wherein thestep of providing an elastic mold further comprises manufacturing saidelastic mold from an elastic material, and said elastic mold may bedesigned for being used once and then disposed of such that a surgeonmay alter and adjust the mold to accommodate an anatomy of the patient.123. The method of forming at least one component of a temporaryprosthetic knee joint of claim 113, wherein the step of placing theamount of biocompatible material within the cavity further comprisessubstantially filling the femoral mold with said biocompatible materialto a desired thickness.
 124. The method of forming at least onecomponent of a temporary prosthetic knee joint of claim 114, wherein thestep of positioning the elastic mold on the portion of the bone furthercomprises locating the femoral mold on a distal end of a femur bystretching and firmly wrapping the femoral mold around a distal portionof the femur.
 125. The method of forming at least one component of atemporary prosthetic knee joint of claim 113, wherein the step ofplacing the amount of biocompatible material within the cavity furthercomprises the step of permitting the biocompatible material to slightlycure before positioning the elastic mold on the portion of the bone.126. The method of forming at least one component of a temporaryprosthetic knee joint of claim 114, wherein the step of removing theelastic mold further comprises scoring, cutting, tearing, ripping,splitting, peeling and otherwise pulling the femoral mold away from thebone and a resulting femoral component of the prosthetic knee joint.127. The method of forming at least one component of a temporaryprosthetic knee joint of claim 113, wherein the step of providing anelastic mold further comprises providing a tibial mold, wherein thetibial mold has an inner base surface comprising at least one protrusionand at least one depression, which are configured for forming acorresponding and opposing at least one depression and at least oneprotrusion in a tibial component of the prosthetic knee joint such thata natural tibial plateau may be, at least in part, simulated.
 128. Themethod of forming at least one component of a temporary prosthetic kneejoint of claim 113, wherein the step of providing an elastic moldfurther comprises providing a tibial mold, wherein the tibial mold has aplurality of markings formed on an outer surface of the tibial mold suchthat a surgeon may use the plurality of markings of the tibial mold as aguide for visually determining a thickness of bone cement needed forfitting between an extension gap formed between a patient's tibial boneand femoral bone.
 129. The method of forming at least one component of atemporary prosthetic knee joint of claim 128, wherein the plurality ofmarkings further comprises a series of symbols representing apredetermined size and thickness of a femoral prosthesis.
 130. Themethod of forming at least one component of a temporary prosthetic kneejoint of claim 113, wherein the step of providing an elastic moldfurther comprises providing a tibial mold, wherein the tibial mold has aplurality of depth rings for scoring, cutting and peeling off an excessportion of said tibial mold, said plurality of depth rings comprising aseries of indentations in an outer surface of the tibial mold configuredfor running a cutting instrument in said plurality of depth rings suchthat the series of indentations acts as a guide.
 131. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of providing an elastic mold furthercomprises providing a tibial mold, wherein the tibial mold has anexternal shape defined by an outer surface of said tibial mold, whereinsaid external shape may be substantially kidney shaped and correspondsto a cross sectional shape of a natural tibial bone.
 132. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of providing an elastic mold furthercomprises providing an elastic tibial mold that may be characterized bythe absence of a substantially enclosed casing.
 133. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the method further comprises the step of making adepth determination that corresponds to a size of a resulting tibialcomponent of the prosthetic knee joint by measuring an extension gapbetween a distal end of a femur and a proximal end of a tibia byutilizing a marking formed on an outer surface of a tibial mold. 134.The method of forming at least one component of a temporary prostheticknee joint of claim 133, wherein the method further comprises the stepof scoring the tibial mold at a desired thickness at the marking byutilizing a plurality of depth rings configured for use as a guide,wherein said plurality of depth rings at least partially circumscribethe tibial mold.
 135. The method of forming at least one component of atemporary prosthetic knee joint of claim 134, wherein the method furthercomprises the step of removing an excess portion of the tibial mold suchthat only the desired thickness for forming the resulting tibialcomponent of the prosthetic knee joint may be obtained.
 136. The methodof forming at least one component of a temporary prosthetic knee jointof claim 113, wherein the step of placing the amount of biocompatiblematerial within the cavity further comprises substantially filling thecavity of a tibial mold with said biocompatible material to a previouslydetermined depth.
 137. The method of forming at least one component of atemporary prosthetic knee joint of claim 113, wherein the step ofpositioning the elastic mold on the bone further comprises positioning atibial mold on a proximal end of a tibia.
 138. The method of forming atleast one component of a temporary prosthetic knee joint of claim 113,wherein the step of placing the amount of biocompatible material withinthe cavity further comprises placing said biocompatible material in atibial mold and permitting the biocompatible material to slightly curebefore positioning the tibial mold on the bone.
 139. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 113, wherein the step of removing the elastic mold furthercomprises removing a tibial mold from the bone and a resulting tibialcomponent of the prosthetic knee joint.
 140. The method of forming atleast one component of a temporary prosthetic knee joint of claim 113,wherein the step of positioning the elastic mold on the portion of thebone further includes stretching the elastic mold around said portion ofsaid bone to thereby affix the elastic mold to said bone in a frictionfit.
 141. The method of forming at least one component of a temporaryprosthetic knee joint of claim 113, wherein the method further comprisesascertaining a gap size using a means for determining the gap sizebetween the proximal tibia and distal femur such that the prostheticcomponent may be formed therebetween and providing an articulationsurface that may allow at least some range of motion.
 142. The method offorming at least one component of a temporary prosthetic knee joint ofclaim 141, wherein the means for determining a gap size includes aspacer block.
 143. The method of forming at least one component of atemporary prosthetic knee joint of claim 141, wherein the means fordetermining a gap size includes calipers.
 144. An elastic femoral moldfor forming a component of a prosthetic knee joint on a patient's femur,said elastic mold comprising: a main body portion comprising a sidewalland an inner base surface that together define a cavity formed withinthe main body portion, said cavity having an open face such that atleast a portion of the sidewall of the elastic mold may be attached tothe patient's femur for forming the component of the prosthetic kneejoint on said patient's femur; an outer surface defining an outer shapeof the elastic mold; wherein said sidewall extends around a perimeter ofthe cavity opposite the outer surface, said sidewall providing a barriersuch that an amount of biocompatible material, configured for use as thecomponent of the prosthetic knee joint, may be poured into the cavityand retained by the barrier within said cavity.
 145. The elastic femoralmold of claim 144, wherein the mold may have a first engagement side anda second engagement side, each engagement side configured for engaging aportion of the patient's femur, and a separation distance formed betweenthe first engagement side and the second engagement side, wherein theseparation distance between the first engagement side and the secondengagement side may be dimensioned to be less than a width of a distalend of the patient's femur such that a secure fit may be formed betweenthe patient's femur and the mold, due, at least in part, to theelasticity of the mold.
 146. An apparatus used in molding a temporaryprosthetic component, in situ, directly on a patient's bone, saidapparatus comprising: a main body portion comprised of an elasticmaterial and formed into a single, unitary mold, said elastic materialpermitting the mold to contact a portion of the patient's bone; an innerbase surface comprising a contour that produces a first surface on theprosthetic component that simulates a natural surface of the bone; and ameans for attaching the mold, in situ, directly to the patient's bone tomaintain the mold temporarily on said bone while a biocompatiblematerial at least partially cures and forms the temporary prostheticcomponent.
 147. The apparatus of claim 146, wherein said inner basesurface comprises at least one depression located substantially in acentral position, and at least one protrusion located laterally of saidat least one depression.
 148. The apparatus of claim 146, wherein saidinner base surface comprises at least one protrusion locatedsubstantially in a central position, and at least one depression locatedlaterally of said at least one protrusion.
 149. The apparatus of claim146, wherein the means for attaching comprises a sidewall defining acavity, said cavity configured for receiving an amount of thebiocompatible material therein.
 150. The apparatus of claim 146, whereinthe elastic material of the mold permits the mold to be easily removedfrom the patient's bone through scoring, cutting, tearing, ripping,splitting, peeling and otherwise pulling the mold apart and removingsaid mold from said bone.
 151. The apparatus of claim 146, wherein themeans for attaching the mold provides a friction fit between the moldand the bone.
 152. The apparatus of claim 151, wherein the friction fitmay be a compression fit.
 153. An elastic mold system for forming aprosthetic knee joint, said elastic mold system comprising: a first moldbeing formed as a one piece mold and having an inner surface and anouter surface, and a cavity defined by a sidewall, wherein said cavitymay be characterized by an open face and configured and dimensioned forreceiving an amount of biocompatible material therein, wherein saidbiocompatible material may be configured for being used as theprosthetic component; a second mold being formed as a one piece mold andhaving an inner surface and an outer surface, and a cavity defined by asidewall, the cavity being configured and dimensioned to receive anamount of biocompatible material therein; wherein the first mold and thesecond mold may both be configured and dimensioned for being located, insitu, on a portion of the patient's femur and tibia, respectively, tothereby form component parts of the prosthetic knee joint; and whereinthe first mold and the second mold may be characterized by the absenceof a substantially enclosed casing such that the first mold and thesecond mold may be attached to the patient's femur and tibia,respectively.
 154. The elastic mold system of claim 153, wherein thefirst mold comprises a femoral mold that may be manufactured from anelastic material, and wherein the first mold further comprises a firstleg and a second leg separated by a gap such that the first and secondlegs form prosthetic femoral condyles of the prosthetic knee joint. 155.The elastic mold system of claim 153, wherein the second mold comprisesa tibial mold that may be manufactured from an elastic material, andwherein the second mold further comprises a base portion formed withinthe inner surface and having at least one protrusion and at least onedepression formed on the base portion such that a prosthetic tibialplateau may be formed in the prosthetic knee joint.
 156. An elastic moldsystem for forming a prosthetic knee joint, said elastic mold systemcomprising: an elastic femoral mold configured for attachment to adistal end of the patient's femoral bone configured for forming a firstportion of the prosthetic knee joint, said first portion comprising anexterior contour dimensioned to simulate natural femoral condyles, saidelastic femoral mold having a first sidewall and an inner surface thattogether define a first cavity, said first cavity having an open facesuch that the femoral mold may be further characterized by an absence ofa substantially enclosed casing; wherein said femoral mold comprises aneyelet formed on an end of the femoral mold for aiding a surgeon inwrapping the femoral mold around a distal portion of the femur and forfurther aiding the surgeon in separating the femoral mold from theresulting first portion of the prosthetic knee joint and the femur;wherein said femoral mold comprises a main body portion, and whereinsaid first sidewall extends around a perimeter of the first cavity andmay be configured to provide a barrier such that an amount ofbiocompatible material, configured for use as the prosthetic knee joint,may be poured into the first cavity and retained within said firstcavity by said first sidewall; wherein said femoral mold comprises aninner surface and an outer surface, and a protruding arched surfacelocated on a portion of said inner surface for forming a correspondingdepression in the first portion of the prosthetic knee joint; whereinsaid femoral mold comprises a medial leg and a lateral leg, each leghaving a substantially arcuate inner surface configured to form aprosthetic femoral condyle that may be dimensioned to simulate thebiomechanics of the natural femoral condyle, said femoral mold furtherhaving a gap formed between and separating the medial leg and thelateral leg wherein the medial leg joins the lateral leg at a junction,said junction defining a crotch portion of the main body portion of thefemoral mold; wherein said femoral mold may be manufactured from anelastic material and substantially filled with the amount ofbiocompatible material such that the femoral mold may be wrapped aroundthe distal portion of the patient's femur to bring the biocompatiblematerial into contact with a surface of the distal portion of the femur,wherein said elastic material permits the femoral mold to stretch,allowing a single femoral mold to accommodate various sizes of distalfemurs, and for peeling the femoral mold away from the first portion ofthe prosthetic knee joint and the femur; and an elastic tibial moldconfigured for attachment to a proximal end of a patient's tibial bonefor forming a second portion of the prosthetic knee joint, said secondportion having an exterior contour simulating a natural tibial plateau,said elastic tibial mold having a second cavity defined by a secondsidewall and an inner surface, and a depth reference feature located onthe second sidewall for making a depth determination and for scoring andcutting away a portion of the elastic tibial mold; wherein said tibialmold comprises an inner base surface with at least one protrusion and atleast one depression thereon configured for forming a corresponding setof at least one depression and at least one protrusion in the secondportion of the prosthetic knee joint such that the natural tibialplateau may be further simulated; wherein said tibial mold comprises amain body portion, and said depth reference feature comprises aplurality of markings formed on an outer surface of the main bodyportion of the tibial mold such that a surgeon may use the plurality ofmarkings of the tibial mold as a guide for visually determining athickness of biocompatible material to be fitted in a gap between thepatient's tibial bone and femoral bone; wherein said plurality ofmarkings comprise a series of symbols representing a predetermined sizeand thickness of the resulting second portion of the prosthetic kneejoint; wherein said tibial mold comprises a plurality of depth rings forscoring, cutting and peeling off an excess portion of the tibial mold,said plurality of depth rings comprising a series of indentations in theouter surface of the main body portion of the tibial mold configured forrunning an instrument in said plurality of depth rings such that theseries of indentations acts as a guide; wherein said tibial moldcomprises an external shape defined by the outer surface of the mainbody portion of the tibial mold, wherein said external shape may besubstantially kidney shaped and corresponds to a cross sectional shapeof the natural tibial bone; and wherein said femoral mold and saidtibial mold are both manufactured from an elastic material that may bedesigned for being used once and then disposed of such that the surgeonmay alter and adjust the mold to accommodate an anatomy of the patient.